Dilon Navigator 2.0 User and Service Manual Rev 8 March 2019

Important Note All personnel that will interact with this Navigator 2.0 System and Probes should read this Manual and Service Guide to ensure proper use, handling, storage and maintenance. This manual applies to white and purple colored Navigator 2.0 systems. The images of both systems are used interchangeably. This document and the information contained herein, is proprietary information of Dilon Technologies and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without prior written consent of Dilon Technologies. This document is intended to be used by customers as part of their Dilon Technologies equipment purchase. Dilon Technologies provides this document without warranty of any kind, implied or expressed, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Dilon Technologies has taken care to ensure the accuracy of this document. However, Dilon Technologies assumes no liability for errors or omissions, and reserves the right to make changes without further notice to any products herein, to improve reliability, function, or design. Dilon Technologies may make improvements or changes in the products or programs described in this document at any time. Navigator 2.0TM is a trademark of Dilon Technologies. Other trademarks and trade names are those of their respective owners.

Copyright Notice Copyright 2018 Dilon Technologies, Newport News, VA 23606 United States of America.

Trademarks Dilon Technologies™ is a registered trademark of Dilon Technologies. All other company and product names are trademarks or registered trademarks of their respective owners.

Part Number N2-5000-07-001 Rev 8 / March 2019

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User Manual: Table of Contents 1.

2.

Introduction ...5 Operating Principle ... 5 Intended Use ... 5 Indications for Use ... 5 Manufacture and Distribution ... 5 Trademarks... 6 Regulatory and Safety Requirements ... 6 System Overview and Components...8

3.

Precautions ... 10

6.

3A. General... 10 3B. Control Unit, Battery, and Charger ... 10 3C. Probe... 11 Control Unit, Battery, Cables, and Co-Pilot ... 12 4A-1. Control Unit Features: Front ... 12 4A-2. Control Unit Features: Back ... 15 4B. Battery (Part # N2-8500-02) ... 17 4C. Cables ... 19 4D. Optional Co-Pilot™ Device (Part # GP-6801-00) ... 20 4E. Useful Adjustments That Can Be Made During Procedures ... 21 Probe Connectivity and Use ... 22 5A. Navigator 2.0 with Wireless Pilot Probe ... 22 5B. Navigator 2.0 with Standard Lymphatic Mapping Probes, Superficial Head & Neck Probe, Daniel Lung Probe, and Laparoscopic Probes ... 25 Troubleshooting... 27

7.

Specifications ... 29

4.

5.

7A. Navigator 2.0 System Specifications ... 29 7B. System Accuracy ... 30 8. Support Items ... 31 8A. Product Part Numbers ... 31 9. Maintenance ... 32 9A. Overview ... 32 9B. Verification of Standard Gain (Calibration Quick Test) ... 32 9C. Fuse Replacement Procedure ... 34 10. Repair ... 36 11. Recycling ... 37 12. Control Unit Cleaning………………………………………………………………………………...37 13. Limited Warranty... 38

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USER MANUAL 1.

Introduction

Operating Principle The Navigator 2.0 System detects presence of gamma rays, emitted from radioactive isotopes in body organs or tissue. System use requires the Navigator 2.0 Control Unit, which allows the user to adjust the system's settings and produces a variety of signal outputs. The control unit is powered by battery. The system provides an increasing or decreasing sound and visual counts that vary as level of gamma radiation increases or decreases. The control unit works in conjunction with a hand-held probe that is connected to the control unit either via a cable or wireless technology. Detecting gamma radiation with a hand-held probe is based on nuclear physics laws which allow detection of radiation emitted from a small source. Placing probe close to a radioactive site increases number of counts detection and localization occurs. Excision of the region of interest is then performed using standard surgical technique. On the other hand, as the distance between the probe and the radiation source is increased, the sound signal and number of counts decrease. The control unit is used with any of the following Navigator™ hand-held probe models. The probes differ primarily in their size, shape, detector technology and connection to the control unit. •

14mm Wireless Pilot Probe™ (angled tip)

•

14mm Standard Lymphatic Mapping Probes (angled tip & straight tip)

•

11mm Superficial Head & Neck Probe (straight tip)

•

10mm Daniel Lung Probe™ (straight tip)

•

10mm Laparoscopic Probes (310mm & 190mm Lengths, straight tips)

The system is supplied non-sterile. This manual includes guidelines for the use of the probes and accessories within the sterile field.

Intended Use For the detection and quantification of gamma radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region.

Indications for Use For the detection and quantification of gamma radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region in open-surgical, laparoscopic or thoracoscopic surgical procedures.

Manufacture and Distribution The system is manufactured and distributed by Dilon Technologies of Newport News, VA. Please direct all inquiries about the Navigator 2.0 to Dilon Technologies. The year of manufacture on the control unit are indicated in the first four numbers of the serial number. The year of manufacture on the probe are indicated in the last two numbers of the serial numbers. N2-5000-07-001 Rev 8

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Trademarks The following are trademarks of Dilon Technologies: Navigator 2.0™, Wireless Pilot Probe™, Dilon Navigator GPS™, Dilon Navigator™, Dilon Technologies Navigator GPS™, Dilon Technologies Navigator™, Dilon Technologies Navigator 2.0™, Daniel Lung Probe™, and Navigator™ when used in context with the above. Navigator GPS® is a registered trademark of Dilon Technologies.

Regulatory and Safety Requirements The Dilon Navigator GPS™ System including Probes and accessories complies with the following standards: EC Directives EMC Directive 89/336/EEC Group l, Class B EN 55011 EMC Directive 89/336/EEC IEC 60601-1-2: 3rd Edition Reciprocal Interference This product has been tested and verified to ensure that there are no issues or concerns regarding reciprocal interference. This includes EMI, EMC and RF. This product has been certified and tested by 3rd party testing facilities. List of standards is as follows: •

Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral Standard: Safety Requirements For Medical Electrical Systems – IEC 60601-1-1: 3 Ed: Amendment 1.

•

Medical Electrical Equipment - Part 1: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility – IEC 60601-1-2: 4th Ed.

Safety •

Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral Standard: Safety Requirements For Medical Electrical Systems – IEC 60601-1: 3rd and 4th Ed.

•

Medical Electrical Equipment - Part 1: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests – IEC 60601-1-2: 3rd and 4th edition.

•

Medical Electrical Equipment - Part 1-6: General Requirements For Safety - Collateral Standard: Usability - IEC 60601-1-6: 2010 + Am. 1: 2013.

•

CAN/CSA C22.2 No. 60601-1, "Medical Electrical Equipment, Part 1: General Requirements for Safety & Essential Performance; issued 2008-02-01 Ed. 2

•

AS/NZS 3200-1-0, Deviations to IEC 601-1 for Application in Australia and New Zealand

CAUTION: Federal (USA) law restricts this device to sale and use by, or on the order of, a physician. N2-5000-07-001 Rev 8

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Navigator 2.0 User Manual & Service Guide Table 1A. Explanation of Symbols

Type-CF Equipment

RX only Caution: Federal (USA) law restricts this device to sale and use by, or on the order of, a physician.

Probe

Date of Manufacture

Data Port

Manufactured by

or

Eject

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Attention, consult accompanying documents

Temperature limitation

Remote Count Control

Humidity limitation

Isotope Control

Serial number

Calibrate Control

Catalogue number

Fuse

European Authorized Representative

Battery

Batch code

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Navigator 2.0 User Manual & Service Guide Table 1A. Explanation of Symbols (Continued)

Battery Power Level

Caution: High Voltage

ON/OFF

Wireless Capability

Acceptable shipping conditions: -15° C to 40° C

WEEE Symbol (EU only)

FCC statements: “This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation.” CAUTION: It is possible that cross communication may occur if two or more wireless devices are used in close proximity IC statements: “This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) This device may not cause interference and (2) this device must accept any interference, including interference that may cause undesired operation of the device.” Cet appareil est conforme avec Industrie Canada RSS exemptes de licence standard (s). Son fonctionnement est soumis aux deux conditions suivantes: (1) Ce dispositif ne doit pas causer d’interférences, et (2) cet appareil doit accepter toute interférence, y compris les interferences qui peuvent causer un mauvais fonctionnement de l’appareil.

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2. System Overview and Components

Navigator 2.0 Control Unit

Control Unit Battery

2-bay Battery Charger and Line Cord

Wireless Pilot Probe Battery

14 mm Wireless Pilot Probe

14 mm Standard Sentinel Node Mapping Probe 11 mm Superficial Head & Neck Probe

10 mm Daniel Lung Probe

10 mm Laparoscopic Probe (310 mm long)

Probes are Type CF Applied Parts. See Table 2A below for a list of Probes. Table 2A. Type CF Applied Parts and Probe Dimensions. Probe

Tip Diameter

Tip Angle

Length

Weight

Wireless Pilot Probe

14mm

30

260mm

255g

14mm 14mm 11mm 10mm 10mm

0 35 0 30 0

224mm 220mm 207mm 465mm 467mm

185g 185g 161g 195g 195g

Standard Lymphatic Mapping Probes Superficial Head & Neck Probe Daniel Lung Probe™ Laparoscopic Probe

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3. Precautions 3A. General •

The output of this system is not to be considered a diagnostic measure of the extent of disease in the patient, nor the recommended source of therapy.

•

Failure to thoroughly review and adhere to the information contained in this User and Service Manual may pose a potential hazard to the patient and/or user and may void the warranty.

CAUTION: To avoid malfunction of the system, only the manufacturer’s approved replacement parts shall be used. This includes the manufacture’s approved replacement parts such as the fuse, control unit battery, 2-bay battery charger, power supply line cord, wireless pilot probe battery, and probe cable. CAUTION: To avoid fire hazard, do not insert a fuse with higher rating than the manufacturer’s specification (0.75A). .

3B. Control Unit, Battery, and Charger •

During system use, maintain electrical isolation of the patient. Do not connect the probe, cable (if used), or the internal circuit of the control unit to earth ground, or to other voltage potentials.

•

Maintain patient electrical isolation. Do not defeat the electrical isolation of the surface of a probe cable (if used), and the control unit housing. These isolate the battery-power circuit inside the control unit, the conductors inside the probe cable, the probe surface, and the patient.

•

The Line Cord of the 2-bay battery charger is used as the disconnect device for the charger.

•

When optional system components are used with the system, maintain probe and patient electrical isolation from earth ground. The optional components include the Co-Pilot™ Device, the probe drape, the Top Gun™ Collimator, and Navigator 2.0 cart.

•

In the operating room, use the charger at a distance of six feet or greater from the patient. The charger has a rating in the United States of a "patient proximity charger.”

•

Fully charge the battery before use in the system.

•

Replace the wireless probe battery with a new battery on EACH day of use, before the first surgical procedure.

•

This system is not designed for use in an explosive atmosphere.

•

Keep the control unit off when changing connections between the probe, cable, control unit and gain module, when used. Control unit should also be off when inserting battery into Wireless Pilot Probe.

•

The control unit, cables, batteries, charger, and probes are sold non-sterile. CAUTION: To avoid the risk of electric shock, the battery charger cord must only be connected to a supply mains with protective earth.

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Navigator 2.0 User Manual & Service Guide CAUTION: To avoid malfunction of the system, no components are to be serviced while the system is in use with a patient. Service activity includes changing batteries, changing fuse, inspecting the probe or cable, and cleaning the probe or cable.

3C. Probe •

DO NOT put any probe or probe cable in an autoclave.

•

With the exception of the Wireless Pilot Probe’s battery bay, DO NOT attempt to open probes. o

All probes are tested and sealed at the factory. Attempting to open the probe may cause damage and will void the warranty.

•

Remove probe battery before cleaning Wireless Pilot Probe.

•

DO NOT drop the probe.

•

DO NOT strike the probe tip against a hard surface; the detector element may become damaged and no longer be able to measure radiation. o

This will also void the warranty.

3C-1. Laparoscopic and Thoracoscopic Probe Use •

This User/Service manual is designed to assist the use of the Navigator 2.0 system and is not a reference to surgical techniques. For information on endoscopic procedures, techniques, complications and hazards, please reference the following publications: Surgical Laparoscopy (Zuker KA ed. St. Louis MO 1991) and Endoscopic Surgery (White RA Klein SR, Mosby Year Book Inc. St Louis MO 1991).

•

This device is intended for use only as indicated. It is not intended for use when endoscopic techniques are generally contraindicated. Please reference Textbook of Laparoscopy (Hulka JF. Grunda and Stratton, Inc. Orlando FL 1985 op114-116) for information on absolute contraindications, high-risk patients and low-risk patients.

•

The use of the Navigator 2.0 system with laparoscopy should only be attempted where there is adequate visualization of the target tissue.

•

Trocars should be placed in accordance with standard laparoscopic and thoracoscopic techniques, with specific regard to target organ geometry to assure probe access to the target organ. Please reference current trocar labeling, suggesting working knowledge of laparoscopic techniques and familiarization with trocar placements under direct visualization through a laparoscope.

CAUTION: Endoscopic procedures should be performed only by physicians with adequate training and familiarity with endoscopic techniques. Medical literature should be consulted relative to techniques, complications, and hazards, prior to the performance of endoscopic procedures.

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4. Control Unit, Battery, Cables, and Co-Pilot 4A-1. Control Unit Features: Front Count Display

10-second Count Button and Indicator

Threshold Control

Isotope Indicators

Calibration –Check Mode Indicator

Range Button and Indicators

Battery Charge Status

Volume Knob

Power Button

Co-Pilot Receptacle Signal Input (Cable Port)

The control unit contains the display, the battery, and most of the system controls. These system controls are located on the front and back of the control unit. The control unit allows the user to adjust the system’s settings and produces signal outputs in the form of a count rate, viewable in the display, as well as an audible pitch that represents the intensity of a probe’s signal. The number of gamma photons (called “events”) shown in the control unit display is determined primarily by a probe and the probe’s position (with respect to the radioactively-tagged tissue), and secondarily by the position of the controls on the control unit.

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Table 4A-1. Controls and Displays on the Front of the Control Unit Control Display

Description Power button: Turns power on and off.

Volume knob: Increases/decreases the volume of the audible signal.

Display Screen: When turned on, displays the photon count per second. Upon completion of a 10-second count, the total number of photons detected will show on the display screen for 4 seconds, and then the display returns to showing counts per second. Isotope Indicator: Indicates the isotope selected. Isotopes detected on the Navigator 2.0 are I125, 511keV (for I-131 or FDG-18), In111, and Tc99. Range Settings: Adjusts the audible pitch, based on density of events detected: 1x – Low event rates; all events are heard. 10x – Medium event rates; 1 in 10 events are heard. 100x – High event rates; 1 in 100 events are heard. Pressing the Range button cycles through the ranges; Select the one most useful to the procedure being performed. NOTE: Range selection only controls pitch of the sound generated by the unit; it has no effect on count rates displayed or signal conditioning. Threshold: For CABLED PROBES only, it controls the count range of photon energy detected by the probe. When the Threshold is off, the indicator is not illuminated, and all photon energy, including scattered photons, is detected. When the Threshold is on, the indicator is illuminated. In this setting, the detection of scattered photons is reduced or eliminated. Signals of amplitude outside the pre-configured energy range are discarded. Only those events within the particular energy range are counted and displayed. NOTE: The Threshold is normally on when using probes. The Threshold may be set to off to count all events detected by a cabled probe. (The Wireless Pilot Probe features integrated threshold) N2-5000-07-001 Rev 8

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Control Display

Description Count: Initiates a 10-second photon count. When Count has been pressed, the count indicator on the display screen is illuminated and the display screen will show increasing counts. Probe must be held in a fixed position for entire duration of 10-second count. When the 10 seconds are complete, the control unit beeps, and the total count is shown in the display. After displaying the total count for four seconds, the display goes back to showing counts per second. Cal-check: This light indicates when the system is in ‘Calibration-Check’ mode on the back of the unit. The light will be illuminated when in any of the 3 calibration-check settings, and will not be illuminated when the system is set to the ‘Scan’ mode. The SCAN / Calibrate Control must be set to the SCAN position only, for all probes for all procedures. In this mode, the ‘Cal’ light will be turned off. See “Verification of Standard Gain (Calibration Quick Test)” for more information on Calibration. The Battery indicator shows the charge status of the battery in use. When the indicator level on the control unit is at 25%, the battery should be replaced immediately with a fully-charged battery. Please note that the charge status on the control unit may differ from charge status reflected on the battery, due to a higher power requirement on the control unit. Refer to charge status on control unit rather than the battery itself. Signal input port, for cable connection. The signal input port is not applicable when using the Wireless Pilot Probe with the Navigator 2.0. For the 12mm Lymphatic Mapping Probe, connect the cable attached to the Gain Module here, matching the arrows on the cable connector to the arrow above the signal input port. See “3mm Diameter Cable” for more information. For all other cabled probes, connect the probe cable here, matching the arrow on the cable connector to the arrow above the signal input port. See “6mm Diameter Cable” for more information.

Connection port for the optional Co-Pilot accessory. See “Optional Co-Pilot Device” for more information.

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4A-2. Control Unit Features: Back

Integrated Handle Scan/Cal-check Control

Fuse Holder

Isotope Control

Pole Mount Connection

Battery Compartment Door

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Table 4A-2. Controls and Displays on the Back of the Control Unit Control Display

Description For CABLED PROBES only. The SCAN position is the only correct position when a probe is being used during a procedure. When set to SCAN, the CAL indicator on the front of the control unit will not illuminate. For instructions on use of the ‘+’, ‘0’, and ‘-‘positions, see “Verification of Standard Gain (Calibration Quick Test)”. Selects the isotope to be detected by the control unit.

SCAN/Calibrate Control For CABLED PROBES only. The SCAN/Calibrate Control has FOUR POSITIONS. During all surgical procedures, this control should be in the SCAN Position. During the calibration verification procedure, this control uses the remaining three settings, “+”, “0”, and “-”. NOTE: See “Verification of Standard Gain (Calibration Quick Test)” for information on calibration verification. NOTE: If the front panel CAL indicator is flashing before a procedure, move the control to the SCAN position. Isotope Control The Isotope Controls allow the user to designate the specific isotope in use.

Switch set on: I125

Switch set on: 511keV

Switch set on: In111

Switch set on: Tc99

Iodine-125

18F-FDG (and I131)

Indium111

Technetium-99m

The Isotope Control setting on the back of the control unit illuminates the corresponding light on the Isotope Indicator on the front of the control unit.

CAUTION: It is important that the isotope control is set to the isotope that is going to be used in the procedure. Setting the isotope control incorrectly will result in incorrect detection. N2-5000-07-001 Rev 8

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4B. Battery (Part # N2-8500-02) 4B-1. Inserting the Battery Open the door to the battery port, located on the right side of the control unit. Insert a fully charged battery with the battery label facing toward the rear of the unit, with battery contacts inward and tab on side of battery positioned outward. Use direction indicator arrow on battery label for guidance.

Shut the door of the battery port. The door will “click” when closed properly. CAUTION: The battery must be removed prior to installing the Pole Mount.

4B-2. Removing the Battery Open the door to the battery port, located on the right side of the control unit. To remove the battery, pull the tab attached to the end of the battery.

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Navigator 2.0 User Manual & Service Guide 4B-3. Charging the Battery (Battery Charger Part # N2-8000-02) Place the charger on a flat, level surface, away from sources of heat and moisture. Plug the DC connector from the power supply into the back of the charger, and connect the power supply to the mains AC, using the cable supplied. All of the LEDs will flash momentarily to indicate that power is present. DC Connector Calibration buttons

Battery Bays

Status window

Recharge Time: Approximately 3.5 hours Place the battery into either battery bay, ensuring that the 5-way connector is fully seated. The battery should feel secure once inserted correctly. The LEDs in the battery status window will provide charge status, and the charger will automatically begin charging. Each charge bay operates independently, providing simultaneous charge of each battery inserted. While there is a calibration button for each bay, calibration is not necessary for use with the Navigator 2.0. If calibration button is inadvertently pressed, either a flashing blue or solid blue light will illuminate. Simply remove battery and reinsert in order to resume charge. A green light will indicate that it is in charge mode. If charger has flashing red light, the battery fuel gauge requires calibration. Only in this case, should the calibration button be pressed. Recalibration can take 10-13 hours. If charger lights solid red, please refer to troubleshooting guide. Table 4B-4. Charge Bay LED Indications Indication

Battery Charge Status

Green Flashing

Battery Charging

Green Solid

Battery Fully Charged

Blue Flashing or Solid

Calibration mode: UNNECESSARY. Do not use.

Red Flashing

Battery fuel gauge in need of calibration

Red Solid

Error

NOTE: Use only batteries supplied by Dilon Technologies. The Dilon Technologies control unit battery has the proper dimensions and a key feature that holds it securely in the Navigator 2.0 control unit.

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NOTE: Approximately 3.5 hours are required to charge a completely drained battery. Having a second, fully charged battery available while the first battery is in use, is recommended. CAUTION: Do not expose the charger or power supply to water or liquids; the case is not sealed. Do not open the charger or power supply case; no user-serviceable parts are inside. Do not cover the fan exhaust or obstruct the airflow. Place the charger away from external heat sources.

4C. Cables In addition to the Wireless Pilot Probe, the Navigator 2.0 may also be used with cabled probes. One of the following two cables is used, depending on the wired probe selected. 4C-2. 6mm Diameter Cable (Part # GP-4001-00) A different cable is used for the standard lymphatic mapping probes (straight or angled), Superficial Head & Neck Probe, laparoscopic probes, and the Daniel™ Lung Probe. This cable has five receptacles inside the probe end, and seven pins inside the plug, that connect to the control unit. The cable is approximately 6mm in diameter. Connect the cable to the control unit, matching the arrows on the cable connector to the arrow above the signal input port.

The connector is a locking connector. To disconnect the cable from the probe and from the control unit, pull directly back on the hood; DO NOT pull or twist on the jacket. WARNING! Do not pull or twist the jacket of the cable, to remove from control unit. You must pull on the hood at the end of the cable. Pulling or twisting the jacket may

damage the cable and render it unusable.

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4D. Optional Co-Pilot™ Device (Part # GP-6801-00) The optional Co-Pilot is a single-use device used for initiating counting periods and adjusting the audible range from the probe, inside the sterile field. It includes two small buttons, and a long, smalldiameter cable. To plug in the Co-Pilot, match the spacing of the prongs with the spacing of the receptacles on the control unit. It should then be clipped onto the base of the probe. The Co-Pilot is supplied sterile and may be used inside or outside of the sterile drape.

R Button (Range) C Button (Count) The “C” button is the COUNT Button. Obtain a one-second count by pushing and releasing this button once. Obtain a ten-second count by pushing this button twice, in quick succession. Each time, total counts are shown in the display screen on the control unit. The “R” button is the RANGE Button. This button operates the Range control mentioned above on the control unit. Push and release the RANGE Button to select an audible range, appropriate to the signal detected by the system. CAUTION: The Co-Pilot can only be attached to the control unit one way – the prongs are not evenly spaced (see image below).

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4E. Useful Adjustments That Can Be Made During Procedures

10-second Count Button and Indicator

Threshold Control

Range Button and Indicators

Power Button Volume Knob

Table 4D-1. Useful Adjustments Adjustment

Benefit

Threshold

For Cabled Probes only, this feature increases specificity when only a low number of events are observed. Threshold control defaults to ON. When ON, the system counts only the events in a narrow energy range around the signal. Change Threshold to OFF to allow the system to count all signals it detects, opening the value range to scatter. (NOTE: The Wireless Pilot Probe features integrated threshold.)

Range

The Range function defaults to 1X, meaning that the audible signal fluctuates according to every single count it detects. In the 10X position, every 10th event produces an audible output. In 100X, only every 100th event produces an audible output. The Range control only affects the sound. The count shown in the display is independent of the range setting.

10-Second Count

Press to obtain a 10-second count, keeping probe in fixed position each time. The total is displayed for at least four seconds, allowing time to record the total.

Volume

Adjust to desired volume.

Power

Press to turn on the control unit or to safely turn off the device.

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